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Regulatory CMC Technical Lead Consultant
Contract type
Ongoing
Work mode
Remote
Experience
Senior · 5+ years
Job description
The CMC Regulatory Affairs role involves authoring and managing CMC regulatory documents for dedicated products to support submissions to regulatory authorities worldwide. It acts as the CMC representative at core team level and advises project teams on CMC regulatory requirements.
At a glance
- Work mode
- Remote
What you'll do
- Maintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities.
- Manage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team, with full responsibility and no need of supervision.
- Act as the CMC representative at core team level with a global role, where required.
- Author and/or review CMC sections of the dedicated portfolio for new marketing authorization applications, investigational applications and variations/ supplements, worldwide.
- Advise to multidisciplinary project teams on regulatory agency requirements and expectations on CMC sections of submission dossier.
- Review and assess change control requests pertaining to CMC aspects of product(s).
- In alignment with CMC functions, agree on the regulatory strategy for the products life cycle and development.
- Maintain submission information according to the document management system, track regulatory CMC commitments & timelines for specific projects/products/markets with minimal supervision.
- Work collaboratively with external CMOs and cross-functional teams on projects like process optimizations, scale up and technology transfer activities.
- In agreement with CMC functions and collaborating with region functions, negotiate with regulatory agencies strategies and actions on CMC sections of submission dossier.
- Support the development of processes and to the preparation of Standard Operating Procedures where required.
- Support due diligence activities on CMC regulatory documents, where required.
- Represent during GMP inspections by regulatory agencies, where required.
- Maintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements.
What we're looking for
- Minimum of a bachelor's degree in a Scientific or Technical Discipline.
- Minimum of 5 years of experience in Regulatory CMC focusing on small molecule drug development.
- Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements.
- Sound knowledge of manufacturing technical transfer and comparability regulatory requirements.
- Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations.
- Proficient in the use of quality management software (e.g. TrackWise) and regulatory document information management system.
- Strong attention to detail. Ability to multi-task, stay organized and prioritize.
- Strong communication skills (oral, written and interpersonal); critical thinking and the ability to identify and recommend solutions to problems.
- Ability to work independently and in a group setting and thrive in a fast-paced environment.
Nice to have
- Additional experience with biologics and Antibody-Drug Conjugates (ADCs) is highly desirable and considered a strong advantage.
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About ClinChoice
Global full-service CRO
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
Mission
To contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices
Key facts
- over 4,000 professionals
- Over 28 years of proven high-quality delivery and results across all our services
- Over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific
- Below industry average turnover rates
What they value
- Diversity and inclusivity
- Continuous training
- Employees are the most valuable company asset